FDA 510(k) clearance · back to tracker

Faros Surgical System

Oertli Instrumente AG cleared K233398 on 2024-06-27, decision: substantially equivalent

K-number

K233398

Sponsor

Oertli Instrumente AG

Device

Faros Surgical System

Class

Class II

Decision

Substantially Equivalent

Decision date

2024-06-27

Product code

HQC

Advisory committee

Ophthalmic

Medical specialty

Ophthalmic

Regulation number

886.4670

Official FDA record

Open K233398on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.